Comparative clinical trial of efficacy and satisfaction of 2% gel lidocaine versus tetracaine/oxybuprocaine anesthetic eye drops in patients undergoing needing techniques in ophthalmology consultations. Anesthesia in Needling with Lidocaine (ANELI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Del Mar

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

11 Jan 2024 → ongoing

Decision date (initial)

2023-12-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Horus Pharma

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the anesthetic efficacy of 2% lidocaine gel with colirofta double anesthetic 1 mg/ml tetracaine hydrochloride + 4 mg/ml oxybuprocaine hydrochloride eye drops in solution in the in-office needling procedure

Secondary objectives 10

1. To describe the sociodemographic characteristics in the study population
2. To determine the degree of comfort of the patient during the procedure
3. To assess the surgeon's perception of pain and patient's collaboration
4. To quantify the need for reinforcement analgesia
5. To determine the need for oral analgesia during the first 24 hours of the procedure
6. To determine the degree of success of the procedure
7. To establish the degree of involvement of the ocular surface through the Oxford classification.
8. To assess security
9. To quantify the reduction of post-procedure IOP.
10. To determine the degree of success of the procedure.

Conditions and MedDRA coding

Glaucoma

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Patients operated on glaucoma surgery with filtration ampoule who require the needling procedure in consultation
2. Over 18 years of age, who have understood and signed the informed consent.

Exclusion criteria 10

1. Pregnant or breastfeeding patients
2. Patients with cognitive impairment who do not understand the numerical rating scale in pain
3. Hearing loss that prevents patient collaboration
4. Anxiety disorder that prevents patient collaboration
5. Allergy to lidocaine, oxybuprocaine, or tetracaine
6. Patients who require needling in the operating room
7. Hypersensitivity to ester-type local anesthetics, other para aminobenzoic acid derivatives or to any of the excipients of Colirofta
8. Hypersensitivity to other amide-type local anesthetics or to any of the excipients of Ophtesic
9. Hypersensitivity to hypromelose gel
10. Patients who require needling in the operating room

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Pain: Numerical rating scale (NRS) from 0 to 10
2. Surgeon comfort/degree of patient cooperation: numerical rating scale (NRS) from 0 to 10

Secondary endpoints 7

1. Demographic variables: sex, age
2. Number of tetracaine booster drops
3. Need for oral analgesia: analgesic and dose used
4. Ocular surface condition: Measured according to the Oxford Scale from 0 to 5.
5. Security: number of intra and post needling complications
6. IOP: Intraocular pressure in mmHg measured by Goldmann applanation tonometry.
7. Absolute success: Number of patients (and percentage) controlled without antihypertensive therapy at 3 months Relative success: Number of patients controlled (and percentage) on hypotensive therapy at 3 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Del Mar

Sponsor organisation

Hospital Del Mar

Address

Passeig Maritim De La Barceloneta 25-29

City

Barcelona

Postcode

08003

Country

Spain

Scientific contact point

Organisation

Hospital Del Mar

Contact name

Maria Jesus Quiroz

Public contact point

Organisation

Hospital Del Mar

Contact name

Maria Jesus Quiroz

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Application history

1 submissions — initial application plus substantial / non-substantial modifications